Kornimate/medical-research-clean huggingface dataset:
dairy and inflammation study

Conditions: Inflammation; Overweight and Obesity; Cardiometabolic Risk

Summary: the purpose of this study is to determine whether 6-weeks of increased dairy consumption can reduce inflammation and other markers of chronic disease while fasted or following a high-fat meal.

following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires, and certain parameters determined from a finger-prick blood sample. eligible participants will be assigned to complete two 6-week dietary interventions in random order, with at least a 4 week "wash out" period (i.e. their habitual eating) in between. the two dietary interventions are: 1) participants normal, low-dairy diet; and 2) a higher dairy diet where 3 servings per day of dairy foods are provided. prior to beginning either 6-week diet intervention, participants will be asked to attend the laboratory at york university after an overnight fast to undergo baseline testing. following baseline testing, participants will meet with a registered dietitian (rd) to discuss each diet arm. specifically, if they are on the dairy diet, participants will receive advice on how to incorporate these dairy foods into their diet by replacing other foods of similar energy content so as to not increase their total energy intake and body weight. they will meet with the rd at several other times throughout the study. during each 6-week diet period, they will be asked to keep their physical activity levels constant and to not adopt any other major dietary changes during the study. at the end of each 6-week intervention period, participants will be asked to return to york university to repeat the initial set of tests performed at baseline. in addition to the fasted tests, a number of tests will be performed after asking participants to consume a high-fat test meal (i.e. a fast-food breakfast). various measurements will continue to be taken for around 6 hours after this meal is consumed.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 25 kg/m2 * ≤ 2 structured exercise sessions/week * habitual low dairy consumption (≤ 1 serving/day) * having at least two other metabolic risk factors based on clinical guidelines: * elevated blood pressure (≥130/≥85 mm hg) * impaired fasting glucose (≥5.6 mmol/l) measured using a finger prick sample * impaired fasting triglycerides (≥1.7 mmol/l) or high-density lipoprotein (\<1.03 mmol/l for males, \<1.3 mmol/l for females) measured using a finger prick blood sample. * increased waist circumference (≥102 cm for males and ≥88 cm for females). * borderline high fasting low-density lipoprotein (≥3.5 mmol/l) or total cholesterol (≥5.2 mmol/l). exclusion criteria: * allergy to dairy foods, diagnosed lactose intolerance or an aversion to foods provided during the study * previous history of diabetes and/or related cardiovascular disease * the use of multiple medications for managing lipids, glucose and/or blood pressure

Keywords: dairy diet inflammation postprandial
home versus postal testing for faecal calprotectin: a feasibility study

Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis

Summary: this trial will test, in a representative group of ibd patients, the acceptability of - and adherence to - the ibdoc test (a new home test for faecal calprotectin in the monitoring of inflammatory bowel disease (ibd)).

crohn's disease (cd) and ulcerative colitis (uc) are forms of inflammatory bowel disease (ibd) that require long-term monitoring. people with these conditions require regular and repeat testing, sometimes with endoscopy, to assess the state of the disease. many centres worldwide now use a stool test called faecal calprotectin (fcalp) as an accurate reflection of endoscopic disease activity - meaning that people with ibd do not need 'routine' endoscopy to assess their disease. fcalp can also be used to give a prediction of what will happen to a person's ibd in the near future. as such, fcalp is an excellent and highly cost-effective test in ibd. however, uptake is often low (as with all stool tests) particularly because the sample needs to be taken at home and delivered in to the laboratory or hospital to be tested. people still therefore need to make an effort to submit samples and find this inconvenient. furthermore, treatments for ibd are increasingly being given at home (usually self-administered injections). while beneficial for people with ibd, it is more difficult to keep track of such patients in the hospital service as they attend less regularly. a test that can be done at home, while making results available to the hospital team, is therefore desirable. new technology allows reliable testing of fcalp at home, using a smartphone app (ibdoc-tm, buhlmann laboratories) within a few minutes. the test kit is packaged with everything required (including gloves, sample 'capture' paper, disposal bag, etc). an instructional video is available within the app itself. apart from testing whether patients adhere to the testing schedule, the investigators will also compare their experiences of the ibdoc test, health anxieties, locus of control, and satisfaction vs postal and traditional 'drop-off' test. validated questionnaires will include: gad7, phq9, ibdc, cbrq and mhlc as well as a proprietary satisfaction questionnaire at the end of the study.

Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease diagnosed at least 6 months prior to study entry * willing to participate in home testing and have smartphone * able to understand english or explanation via interpreter, and provide written consent exclusion criteria: * participants without smartphone (android or ios) * unable to understand english (excl. via interpreter) * no previous experience of submitting stool samples for faecal calprotectin measurement
g-pola-zlp in diffuse large b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the goal of this phase 2 trial is to test the safety and efficacy of g-pola-zlp as induction therapy in patients with dlbcl.

the investigators will evaluate safety and efficacy of g-pola-zlp as induction therapy in previously untreated diffuse large b-cell lymphoma. orr(overall response rate, progression-free survival (pfs), overall survival (os), adverse events (aes) will be assessed.

Eligibility criteria:
inclusion criteria: * pathologically confirmed diffuse large b cell lymphoma according world health organization (who) classification; * patient is ≥ 18 years of age at the time of signing the informed consent form (icf). * patient must understand and voluntarily sign an icf prior to any study-specific assessments/procedures being conducted; * patient is willing and able to adhere to the study visit schedule and other protocol requirements; * patient has not received chemotherapy previously. * anticipated life expectancy at least 3 months exclusion criteria: * active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy. * pregnant or lactating women
progressive exercise after operation of rotator cuff rupture and anterior labrum rupture

Conditions: Rotator Cuff Disease; Shoulder Joint

Summary: the purpose of this study is to evaluate the effectiveness of progressive strength training after rotator cuff and labrum operation of the shoulder joint.


Eligibility criteria:
inclusion criteria: * rupture of rotator cuff * rupture of anterior labrum * age 18 to 65 years * motivated to continue in work life * motivated for rehabilitation exclusion criteria: * former operation in the same joint * major arthrosis in the same joint * cervical disk herniation * concised spinal cord * conditions after cervical spine operations * rheumatic diseases * fibromyalgia * pregnancy * severe depression * alcoholism * misusing of drugs * disease that prevents progressive exercise eg. back pain, heart disease

Keywords: shoulder joint recovery of function effectiveness of rehabilitation rehabilitation
to assess the efficacy and safety of vildagliptin as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy

Conditions: Diabetes Mellitus, Type 2

Summary: this study is not being conducted in the united states. vildagliptin is an oral antidiabetic agent. this 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea * patients on diet and exercise who have not reached target blood glucose levels * outpatients exclusion criteria: * type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * significant cardiovascular complications as defined by the protocol * significant diabetic complications as defined by the protocol other protocol-defined inclusion/exclusion criteria may apply.

Keywords: type 2 diabetes vildagliptin hba1c
research study looking at how well semaglutide tablets taken once daily work in people who have a body weight above the healthy range

Conditions: Overweight; Obesity

Summary: this study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. this study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study * male or female, age greater than or equal to 18 years at the time of signing informed consent * body mass index (bmi) of * greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (cv) disease or * greater than or equal to 30.0 kg/m\^2 * history of at least one self-reported unsuccessful dietary effort to lose body weight exclusion criteria: * a self-reported change in body weight greater than 5 kg (11 pound \[lbs\]) within 90 days before screening irrespective of medical records * hba1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
iclusig pms in cml or ph+all patients

Conditions: Chronic Myeloid Leukemia; Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Summary: this is a post-marketing surveillance (pms) of iclusig® tablets in accordance with korean regulations on risk management plan (rmp). this pms is to assess safety and effectiveness data after administrating ponatinib (of iclusig® tablets) per approved indication, usage and dosage.


Eligibility criteria:
inclusion criteria: * patients who are prescribed iclusig® per prescribing information (pi) for the purpose of treatment exclusion criteria: * patients with known or suspected hypersensitivity to ponatinib or to any ingredient of the drug * patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption
fecal calprotectin collection protocol

Conditions: Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Ulcerative Colitis; Crohn Disease; Indeterminate Colitis; Chronic Diarrhea; Celiac Disease; Diverticulitis; Abdominal Pain; Distension; Weight Loss; Food Intolerance; Constipation

Summary: the primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of ibd and/or ibs will be evaluated in this study. eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.

stools will be collected and tested, at a later date, in a clinical performance study with an investigational calprotectin assay. this study will be coordinated by the sponsor.

Eligibility criteria:
inclusion criteria: * subject is of either gender and ≥ 4 years of age. * subject is showing signs and symptoms of ibd and/or ibs. * diagnosis of ibd, ibs or other gastrointestinal disorder is performed by colonoscopy. * subject or authorized legal representative is willing and able to sign the irb approved informed consent form or able to provide informed consent in accordance with 21 cfr 50 cfr 50 subpart b. * subject is able to understand and follow study sample collection procedure. exclusion criteria: * subject has undergone a surgical resection or diversion procedure. * subject is currently taking nsaids (non-steroidal anti-inflammatory drugs, i.e. ibuprofen, advil, motrin, naproxen, aleve including regular dose and low dose aspirin) within 7 days of colonoscopy and sample collection. * subject who has taken immunomodulators or biologic therapies within the previous 6 months of colonoscopy and sample collection. * subject who is currently pregnant or lactating. * subject is unable or unwilling to follow informed consent. * inability or unwilling to perform required study procedures.

Keywords: inflammatory bowel diseases irritable bowel syndrome ulcerative colitis crohn disease indeterminate colitis
delirium and neuropsychological recovery among emergency general surgery survivors

Conditions: Delirium

Summary: this study will evaluate the usefulness of the urgent and emergency surgery (ues) delirium recovery model. it is hypothesized that the cognitive, physical and psychological recovery of older ues delirium survivors will be improved through the use of the dane recovery model. participants can expect to be on the study for 18 months.

this is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the dane recovery model to improve the cognitive, physical and psychological recovery of older ues delirium survivors. at or near the time of discharge, enrolled participants will be randomized to receive the dane recovery model or usual care. the hypothesis is that, after 18 months, older ues delirium survivors who are randomized to the dane recovery model will experience more favorable cognitive, physical and psychological recovery in comparison to those randomized to usual care.

Eligibility criteria:
inclusion criteria: * adult age 65 years and older * admitted to one of the participating hospitals * undergone an abdominal orthopedic, skin, or vascular surgery in an emergency or unplanned fashion * english-speaking * able to provide consent or have a legally authorized representative to provide consent * access to a telephone or an internet connected computer or smart device * discharged to home or sub-acute rehabilitation * at least one episode of delirium or subsyndromal delirium, i.e. screen positive on at least one out of the four items on the confusion assessment method-icu (cam-icu) in the period prior to discharge from acute care. exclusion criteria: * a self-reported diagnosis of cancer with short life expectancy * a history of dementing illnesses and other neurodegenerative disease such as alzheimer's disease (ad), parkinson disease, or vascular dementia, or current prescription of anti-dementia medication, or ruled out by functional activities questionnaire (faq) score defining dementia; a history of significant traumatic brain injury * acute or subacute neurologic deficit expected to prevent independent living after hospital discharge, e.g., a history of a significant traumatic brain injury * have any spinal cord injury with persistent neurologic deficit at the time of study enrollment * incarcerated or homeless at the time of study enrollment * acquired neurologic injury (stroke, traumatic brain injury, cerebral edema/swelling, anoxic brain injury, or any other acute/subacute severe neurologic deficit) as the admitting diagnosis or a new event during the course of hospitalization (confirmed by emr) * a history of bipolar disorder or schizophrenia (confirmed by emr)
correlation of serum adalimumab levels at an administration of 40 mg weekly vs 80 mg every two weeks

Conditions: Inflammatory Bowel Diseases

Summary: rct to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.

ibd patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups.

Eligibility criteria:
inclusion criteria: * patients \> 18y * intensified adalimumab regime at least 4 weeks prior to enrollment. * immunosuppressants are allowed if a stable dose for \> 12w is maintained. * corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained. exclusion criteria: * patients unable to understand study protocol, study procedures or not capacitated to give informed consent. * pregnant or lactating women.

Keywords: antitnf inflammatory bowel diseases adalimumab therapeutic drug monitoring
substance misuse to psychosis for stimulants

Conditions: Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis); Schizophrenia and Related Disorders; Stimulant Dependence; Stimulant Abuse; Pharmacotherapy

Summary: in hong kong, less than 5% of stimulants abusers were reported to misuse these substances via injection. also, it is well known that patients with co-morbid substance abuse/dependence and psychosis or schizophrenia-related disorders are prone to earlier treatment discontinuation and high oral medication non-adherence, resulting in poorer overall outcomes. with the recent availabilities of the 4-weekly long-acting injectable form of aripiprazole, and the 4-weekly and the 3-monthly long-acting injectable form of paliperidone palmitate, on the background of the surging phenomenon of stimulant misuses in hong kong, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with substance use disorders with psychosis to develop into a more chronic disabling dependence or co-morbid state.


Eligibility criteria:
inclusion criteria: • stimulant use disorder with psychosis or positive stimulant urine test results twice in a month with psychosis exclusion criteria: * age \<16 years old * unable to read english or chinese * unable to give informed consent * had been diagnosed to have intellectual disabilities (dsm-5) or mental retardation (icd-10 f70-73) * had been diagnosed to have schizophrenia * had been diagnosed to have other substance-induced psychotic or mood disorder, including alcohol * had been diagnosed to have bipolar disorder viii. had been diagnosed to have major depressive disorder with psychotic features * had been taking any maintenance dose of oral antipsychotics continuously ≥12 weeks and with psychotic symptoms in remission * had been receiving any maintenance dose of long-acting injectable (lai/depot) antipsychotics continuously ≥4 month and with psychotic symptoms in remission * had known hypersensitivity to risperidone (oral or lai), paliperidone (oral or lai), or aripiprazole (oral or lai) * had known history of tardive dyskinesia * had known history of neuroleptic malignant syndrome * pregnant * mother currently breast-feeding * had history of prolonged corrected qt interval (qtc) ≥500ms and/or known unstable or untreated cardiac disorder * had mild to severe renal impairment with glomerular filtration rate \<80 mililitre /min

Keywords: stimulant psychosis schizophrenia dependence pharmacotherapy
breast milk composition and hiv-exposed/unexposed early infant growth and infectious disease events

Conditions: HIV; Malnutrition; Cryptosporidiosis

Summary: the purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. by following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in northern tanzania.


Eligibility criteria:
inclusion criteria: * informed consent provided by mothers, and parental consent on behalf of their infants * confirmed maternal hiv status (hiv-1, hiv-2 or hiv-dual seropositive or hiv-seronegative) * stated intention to remain in the clinic catchment area ≥6 months post-partum * singleton birth exclusion criteria: * none
association between a multi-gene panel and renal denervation effectiveness in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to assess the effectiveness of a multi-gene panel to determine which subjects are likely to respond to renal denervation therapy with medtronic's symplicity spyral™ multi-electrode renal denervation system.

the objective of this study is to assess if renal denervation (rdn) effectiveness using the symplicity spyraltm multi-electrode renal denervation system is associated with ranked genomic scoring from the geneticure multi-gene algorithm for renal denervation. the present study will assess if subjects who have a high genetic score, based on the hypothesized importance of the organ systems involved, will have differential responsiveness to rdn in a descending order. the genetic scoring is collectively ranked in a specific order, in that: * subjects with a "high level of general functionality" (functionality in the sympathetic nervous system (sns), cardiac, vascular (renin-angiotensin-aldosterone system (raas)), and renal system genotypes will be most responsive to rdn. * subjects with high number of functional genotypes of sns, cardiac, and raas will be the next most responsive group. * subjects with functionality in genotypes of sns and cardiac systems will demonstrate the next most responsive group. * subjects with functionality in the sns genotypes will demonstrate some degree of responsiveness. * subjects with functionality in the renal system, but not sns, cardiac, nor raas, will be the least responsive to this therapy.

Eligibility criteria:
inclusion criteria: 1. individual is currently or has previously been enrolled in a medtronic clinical study utilizing the symplicity spyral™ multi-electrode renal denervation system. 2. subject received renal denervation. 3. subject has met the primary efficacy endpoint for the medtronic symplicity spyral study and which arm they were randomized to. 4. individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study. exclusion criteria: * unable to provide written, informed, consent